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Section 904(a)(3) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, (FDCA) requires manufacturers and importers to report the quantities of Harmful and Potentially Harmful Constituents (HPHCs) found in their tobacco products, or in the smoke produced by their products, by brand and sub-brand.  21 U.S.C. § 387d(a)(3).  This

Learn how to stay in compliance with FDA’s recent announcements and much more at Keller and Heckman’s upcoming E-Vapor and Tobacco Law Symposium on January 29 – 30, 2019, in Miami, Florida. Below is a sampling of topics that will be covered at the event. Sign up now and take advantage of our early bird

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Tobacco product manufacturing establishments in the United States must register with the Food and Drug Administration (FDA) immediately upon beginning manufacturing operations (e.g., the manufacture, preparation, compounding, or processing of a tobacco product).  As part of the registration process, establishment operators must submit a detailed list of products manufactured at the establishment, along

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February 26, 2018 – Keller and Heckman LLP is pleased to announce the introduction of its Audit and Inspection Program (AIP) for Tobacco and Vapor Product Manufacturing Establishments.

The AIP was developed in response to the Food and Drug Administration’s (FDA) inspection authority under the Food, Drug, and Cosmetic Act (FDCA or the Act), as